Governance Perspectives on Genetically Modified Animals for Agriculture and Aquaculture: Challenges for the Assessment of Environmental Risks and Broader Societal Concerns.

Biotechnological applications in animals are increasingly developed for use in agriculture and aquaculture to tackle breeding challenges in animal production. By examining two case studies of genetically modified (GM) farmed animals relevant to the European Union, slick-haired cattle and growth-enhanced carp, we highlight the challenges for environmental risk assessment and discuss available assessment approaches to address broader societal concerns. We find that the existing guidance for environmental risk assessment of GM animals available in the European Union faces several challenges. Assessing risks of GM animals in agriculture and aquaculture requires consideration of the farming systems of these animals. In addition, we find that there is a lack of guidance and practical implementation to address wider issues, including cultural, societal, ethical, and socio-economic issues, as well as animal health and welfare issues, related to GM farmed animals. We propose using existing assessment frameworks to address the sustainability of GM farmed animals beyond environmental risk assessment. Sustainability assessment approaches should also address potential farm-level sustainability claims of GM animal applications. We note that issues related to animal health and welfare are cross-disciplinary topics that require special attention when commercializing GM farmed animals. We recommend developing a comprehensive framework, including risk assessment, sustainability assessment, and technology assessment, that will enable policymakers to better anticipate and address the societal, legal, ethical, and governance issues associated with emerging biotechnologies in farmed animals.